NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU)

Polymer Patient Examination Glove

HARTALEGA NGC SDN. BHD.

The following data is part of a premarket notification filed by Hartalega Ngc Sdn. Bhd. with the FDA for Nitrile Powder Free Examination Glove - Aqua Blue (ablu) / Violet Blue (vblu) / Dark Blue (dkbu).

Pre-market Notification Details

Device IDK140610
510k NumberK140610
Device Name:NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU)
ClassificationPolymer Patient Examination Glove
Applicant HARTALEGA NGC SDN. BHD. C-G-9, JALAN DATARAN SD1 Bandar Sri Damansara,  MY 52200
ContactNurul Aisyah Kong
CorrespondentNurul Aisyah Kong
HARTALEGA NGC SDN. BHD. C-G-9, JALAN DATARAN SD1 Bandar Sri Damansara,  MY 52200
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-10
Decision Date2014-06-20
Summary:summary

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